CAN CSA-Z364 1 3-1998 Reuse of Haemodialysers (First Edition General Instruction No 1 December 1998 Update No 2 June 2002).pdf

1、Z364.1.3-98(reaffirmed 2014)Reuse of HaemodialysersLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representin

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21、 Standard of Canada(approved June 2002)CAN/CSA-Z364.1.3-98Reuse of Haemodialysers Prepared byRegistered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaPublished in December 1998 by Canadian Standards AssociationA not-for-profit private sector organization178 Rexdal

22、e Boulevard, Toronto, Ontario, Canada M9W 1R31-800-463-6727 416-747-4044Visit our Online Store at www.csa.caTechnical Editor: Andre WisaksanaManaging Editor: Gary BurfordSenior Project Editor: Ann MartinEditors: Maria Adragna/Sandra HawrynPublishing System Coordinators: Ursula Das/Grace Da Silva/See

23、tha Rajagopalan Canadian Standards Association 1998All rights reserved. No part of this publication may be reproduced in any form whatsoeverwithout the prior permission of the publisher.(Copyright page replaced June 2002)General Instruction No. 1Z364.1.3-98December 1998Title: Reuse of Haemodialysers

24、Pagination: 36 pages (x preliminary and 26 text), each dated December 1998To register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2007371.If you require assistan

25、ce, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we protect your personal information.Blank pageZ364.1.3-98 Reuse of Haetnodialysers ISSN 0317-5669 Published in December 7998 by Canadian Standards Association 778

26、Rexdale Boulevard Etobicoke, Ontario, Canada M9W 7R3 Technical Editor: Andre Wisaksana Managing Editor: Gary Burford Senior Project Editor: Ann Martin Editors: Maria Adragna/Sandra Hawryn Publishing System Coordinators: Ursula Das/Grace DaSilva/Seetha Rajagopalan Canadian Standards Association - 799

27、8 All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. CSA Contents Technical Committee on Extracorporeal Circulation Technology vi Subcommittee on Reprocessing of Haemodialysers viii Preface x 1. Scope 2. Definition

28、s and Abbreviations 2.1 Definitions 1 2.2 Abbreviations 4 3. Reference Publications 5 4. Documentation Requirements 5 4.1 Patient Record 5 4.2 Dialyser Reprocessing Manual 6 4.3 Reprocessing Record 6 4.4 Equipment Maintenance Records 6 4.5 Personnel Health Monitoring Records 6 4.6 Complaint/Incident

29、 Investigation Records 6 4.7 Quality Assurance (QA) and Quality Control (QC) Records 7 5. Personnel Qualifications and Training 7 5.1 Qualifications 7 5.2 Training 7 6. Patient Considerations 8 6.1 Medical Issues 8 6.2 Patient Information Requirement 8 6.3 Haemodialyser Reuse 9 7. Equipment 9 7.1 Ge

30、neral 9 7.2 Water Systems 9 7.2.1 General 9 7.2.2 Disinfection 9 7.2.3 Testing Water Quality 10 7.2.4 Monitoring Water Quality 10 7.3 Reprocessing Systems 10 7.3.1 UtilityRequirements 70 7.3.2 Process Control Testing 10 7.3.3 Maintenance 70 7.3.4 Repairs 11 8. Physical Plant and Environmental Safety

31、 Considerations 11 8.1 General 11 8.2 Reprocessing Area and Ventilation 71 8.3 Storage Area 12 December 7998 Reuse of Haemodia/ysers iii Z364. 7.3-98 8.3 Storage Area 72 8.4 Laboratory Area 72 8.5 Personnel Protection 72 8.6 Environmental Safety 72 9. Reprocessing Supplies 73 9.1 Specifications and

32、Testing 73 9.2 Inventory Control 13 10. Haemodialyser Labelling 13 10.1 General 13 10.2 Time of Labelling 13 10.3 Label Composition 73 10.4 Information Recorded 14 11. Reprocessing 14 12. Transportation and Handling of Haemodialysers 14 12.1 General 14 12.2 Handling 74 12.3 Handling, Transport, and

33、Storage 74 13. Rinsing and Cleaning of Haemodialysers 14 13.1 Interior/Blood Compartment 14 13.2 Exterior 75 CSA 14. Performance Measurements and Requirements for Reprocessed Haemodialysers 15 14.1 Performance Test after Each Use 15 14.1.1 Clearance-Based Rejection 15 14.1.2 Total Cell Volume-Based

34、Rejection 75 14.1.3 Other Rejection Criteria 15 14.2 Ultrafiltration 16 14.3 Blood Path Integrity Test 76 15. Haemodialyser Disinfection/Sterilization 16 15.1 Blood and Dialysate Compartments 16 15.2 Ports 16 15.3 Rinse Water 16 15.4 Chemical Germicides 76 16. Heat Process 76 16.1 Recording 76 16.2

35、Membrane Integrity 76 16.3 Disinfectant 17 17. Chemical Process 77 17.1 General 77 17.2 Chemical Germicide Diluent 17 1 7.3 Chemical Germicide Concentration 77 18. Post-Processing Inspection 1 7 18.1 Examination 77 1 8.2 Jacket 18 iv December 7998 CSA 1 8.3 Leaks and Cracks 18 18.4 Exterior of Hollo

36、w Fibres 18 18.5 Headers 18 18.6 Ports 18 1 8.7 Label 18 19. Disposition of Rejected Dialysers 18 19.1 Storage 18 19.2 Disposal 18 20. Storage 18 20.1 General 18 20.2 Prolonged Storage 18 21. Preparation for Dialysis and Testing for Chemical Germiddes and Potentially Toxic Residues 19 21.1 General 1

37、9 21.2 Visual Inspection 19 21.3 Verification of Patient Information 19 21.4 Verification of Germicidal Contact 19 21.5 Process Control and Sampling 20 21.5.1 General 20 21.5.2 Process Control 20 21.5.3 Sampling 20 21.6 Priming the Dialyser and Rinsing of the Germicide 20 21.7 Testing for Residual G

38、ermicide 20 21.8 Written Procedure for Tests for Germicide or Other Residues 21 22. Monitoring 21 22.1 Dialysis 21 22.2 Symptoms 22 22.2.1 Fever and Chills 22 22.2.2 Other Symptoms 22 22.2.3 Recording 22 22.3 Dialyser Failures 22 22.4 Clinical Results 23 23. Quality Assurance 23 23.1 General 23 23.2

39、 Audit Schedules 24 Tables 25 Figure 26 December 1998 Reuse of Haemodialysers v Z364. 7.3-98 Technical COln:tnittee on Ex tracorporea I Circulation Technology S.S.A. Fenton The Toronto Hospital, Toronto, Ontario V.S. Blanchette The Hospital for Sick Children, Toronto, Ontario R. Cobbledick Health Ca

40、nada, Ottawa, Ontario s. Comeau-Geddry New Brunswick Nurses Association, Fredericton, New Brunswick J.E. Dadson Medionics International Incorporated, Markham, Ontario W. Demajo The Toronto Hospital, Toronto, Ontario H.P. Demshar Ministry of Health, Toronto, Ontario G. deVeber Baxter Corporation, Mis

41、sissauga, Ontario P. Fabry Canadian Standards Association, Etobicoke, Ontario J. Gryn Canadian Standards Association, Etobicoke, Ontario D. Hollomby University Hospital, London, Ontario W.Lepp Health Sciences Centre, Winnipeg, Manitoba J. MacDonald University Hospital, London, Ontario R. V. Merrick

42、IVAC Corporation, San Diego, California, USA J.D. Stewardson Cobe Laboratories Incorporated, Lakewood, Colorado, USA V. CSA Chair Associate December 7998 CSA D. Weatherill R.D. Weisel C. Cillis December 1998 Biolab Equipment Canada Limited, Oakville, Ontario The Toronto Hospital, Toronto, Ontario Ca

43、nadian Standards Association, Etobicoke, Ontario Reuse of Haemodialysers Project Manager VII Z364.7.3-98 Subcornrnittee on Reprocessing of Haernodialysers D. Hollomby University Hospital, Co-Chair London, Ontario s. Vas The Toronto Hospital, Co-Chair Toronto, Ontario J. Boileau Jewish General Hospit

44、al, Montreal, Quebec L. Braganza Cobe Canada Limited, Scarborough, Ontario G. Burford Canadian Standards Association, Etobicoke, Ontario R. Cobbledick Health Canada, Ottawa, Ontario s. Drain Winnipeg Hospital Authority, Winnipeg, Manitoba C. Estridge The Toronto Hospital, Toronto, Ontario C. Fedele

45、Baxter Healthcare Corporation, McGaw Park, Illinois, USA R. Francoeur The Wellesley Hospital, Toronto, Ontario T. Greene St. Josephs Hospital, Hamilton, Ontario A.K. Gryka St. Michaels Hospital, Toronto, Ontario C. Harding Health Sciences Centre, St. Johns, Newfoundland D.C. Jamieson Canadian Cardio

46、vascular Products Ltd., Mississauga, Ontario B. Johnson Minntech Corporation, Minneapolis, Minnesota, USA CSA viii December 1998 CSA P. Loughren S. Mehrabian E. Morton J. Parks F. Soliman S. Tetley B. Wilkinson A. Zita A. Wisaksana December 1998 Georgian College of Applied Arts (b) provide an explan

47、ation of circumstances surrounding the actual field condition; and (c) be phrased where possible to permit a specific “yes“ or “no“ answer. Committee interpretations are processed in accordance with the CSA Directives and guidelines governing standardization and are published in CSAs periodical Info

48、 Update. For subscription details, write to CSA Sales Promotion, Info Update, at the address given above. x December 1998 CSA Z364.1.3-98 Reuse of Ha ellf 0 dia lysers 1. Scope 1.1 Reuse of Haemodialysers This Standard details the essential elements of good practice for reprocessing haemodialysers.

49、It is intended to provide the administrator with a standard practice regarding the reprocessing of haemodialysers. Notes: (1) This Standard does not endorse either single-use or reuse of haemodialysers. (2) There are various haemodialysis systems. Some are single-use and some are reusable. (3) Haemodialyser characteristics such as biocompatibility and clearance of larger molecules ar